Identification of Genes Associated With Cancer in Patients & Siblings Who

Status Completed

Clinical Trial Summary

RATIONALE: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer. PURPOSE: This clinical trial is studying to see if certain genes may be associated with cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these patients.

Clinical Trial Description

OBJECTIVES: - Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer. - Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1. - Generalize this approach for one of four cancers (breast, colon, lung, or prostate), using allele-sharing statistics to test the interaction of each locus with every other locus. - Replicate positive results in a distinct set of sibling pairs with cancer. - Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival. OUTLINE: Each patient-sibling pair completes a family history questionnaire about the incidence of cancer in the family. Blood samples are obtained from both the patient and the sibling (and both living parents, if available). The blood samples are genotyped using approximately 300 micro-satellite markers flanking 100 candidate genes previously implicated in genetic risk for cancer. Certain loci are a priority due to their association with HRAS1: BRCA1 and all known mismatch repair loci; other repair genes, such as ATM; the Bloom's syndrome locus; and the XRCC group. Other genes are also mapped. Patients do not receive the results of the genetic testing and the results do not influence the type and duration of treatment. Patients only are followed annually. PROJECTED ACCRUAL: This study will accrue 1,000 patient-sibling pairs for breast cancer. After 18 months, another 1,000 patient-sibling pairs will be accrued for breast cancer. Therefore, up to 2,000 patient-sibling pairs will be accrued over 5 years. (Feasibility of accruing pairs for lung, colon, and prostate cancer is being assessed.) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00003329
Study type	Observational
Source	Eastern Cooperative Oncology Group
Contact
Status	Completed
Phase
Start date	April 7, 1998

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms